Kornimate/medical-research-clean huggingface dataset:
early use of hyperimmune plasma in covid-19

Conditions: Covid19

Summary: the study assesses the efficacy of early administration of hyperimmune plasma in covid-19 patients who are on cpap or intubated. efficacy is measured as a 2 point decrease in the who scale

patients who satisfy eligibility criteria and in particular have started positive pressure respiratory support not more than no more than 48 hours are administered 200 to 300 ml in 2 or 3 times administered over a time window of 5 days. . plasma titration will depend on the availability in the local plasma bank; any titre ≥ 1:80 will be acceptable. primary endpoint will be assessed at 28 days; vital status will be further investigated at 3 and 6 months.

Eligibility criteria:
inclusion criteria: 1. written informed consent prior to performing study procedures. witnessed oral consent will be accepted in order to avoid paper handling. written consent by patient or representatives will be obtained as soon as possible. 2. male or female adult patient ≥18 years of age at time of enrolment. 3. laboratory-confirmed sars-cov-2 infection as determined by real-time rt-pcr in naso/oropharyngeal swabs or any other relevant specimen.. 4. patient is hospitalized for covid-19, is severely hypoxic with a p/f ≤ 200 while breathing room air or supplemental oxygen and requires positive pressure respiratory support, either non-invasive (helmet/mask cpap or niv) or invasive (endotracheal intubation and mechanical ventilation) 5. no more than 48 hours between the onset of positive pressure respiratory support and treatment administration day 6. evidence of pulmonary infiltrates at chest imaging (chest x-ray, ct scan or lus) 7. the patient is not eligible in the tsunami trial. exclusion criteria: 1. participation in any other clinical trial of an experimental treatment for covid-19. 2. in the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. 3. stage 4 severe chronic kidney disease or requiring dialysis (i.e. egfr \<30). 4. pregnancy 5. current documented and uncontrolled bacterial infection.

Keywords: hyperimmune plasma positive pressure respiratory support
a pilot study to compare the antiviral and immunologic effects of stavudine ( d4t ) versus placebo in subjects with evidence of recent hiv infection.

Conditions: HIV Infections

Summary: to compare the antiviral effect of stavudine ( d4t ) versus placebo in patients with evidence of recent hiv infection. also, to compare the immunologic effects and effects on quality of life of d4t in these patients.

patients receive d4t or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. treatment continues for at least 48 weeks.

Eligibility criteria:
inclusion criteria patients must have: * recent hiv infection. * no prior antiretroviral therapy. * no acute opportunistic infection at study entry. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * intractable diarrhea. * bilateral peripheral neuropathy. * any other condition that would preclude study therapy. concurrent medication: excluded: * myelosuppressive, neurotoxic, or hepatotoxic drugs. patients with the following prior condition are excluded: history of bilateral peripheral neuropathy. prior medication: excluded: * prior antiretroviral therapy. * myelosuppressive, neurotoxic, or cytotoxic agents within 3 months prior to study entry.

Keywords: aids-related complex stavudine
clip placement following endoscopic mucosal resection - randomised trial

Conditions: Colonic Polyps

Summary: patients will be randomised to have endoscopic clips applied to the endoscopic mucosal resection (emr) site following complete removal of the lesion, or will not receive clips and proceed with standard of care.

the outlined literature suggests that colonic post emr bleeding may be prevented by the use of prophylactic endoscopic clips. there has thus far been no prospective study to confirm this concept. the ideal way to prove the hypothesis is to conduct a randomised controlled trial to evaluated the use of prophylactic clip placement on the emr resection defect, for the purpose of preventing delayed bleeding in colonic wide field emr (lesions\>20mm). given the significantly increased rate of bleeding in the proximal colon, clip placement in this location may have the greatest benefit. if it is proven that such a prophylactic technique is effective and safe, it may lead to significantly decreased patient morbidity and health care resources associated with the management delayed bleeding.

Eligibility criteria:
inclusion criteria: * can give informed consent to trial participation * lesion size greater than 20 mm * lesion proximal to and inclusive of mid transverse colon * laterally spreading or sessile polyp morphology exclusion criteria: * previous resection or attempted resection of lesion * clip deployed prior to the completion of the emr * major intraprocedural bleeding not treatable by coagulation * endoscopic appearance of invasive malignancy * age less than 18 years * pregnancy * active inflammatory colonic conditions (e.g. inflammatory bowel disease) * use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior to procedure * american society of anesthesiology (asa) grade iv-v
respiratory mechanics assessment during assisted mechanical ventilation

Conditions: Acute Hypoxemic Respiratory Failure

Summary: to verify the association between respiratory system mechanical properties (δp, δpl,dyn, pmus, pplat and crs and cl,dyn) assessed during assisted modes of ventilation (as average over the first three days since enrollment) and icu mortality.


Eligibility criteria:
inclusion criteria: * acute hypoxaemic respiratory failure (defined as respiratory failure requiring invasive mechanical ventilation with a pao2/fio2\< 300 mmhg) during the course of icu stay (including ards). * invasive mechanical ventilation in one of these modes: pressure a/c, prvc, simv pc, psv, nava, pav+, bipap * presence of spontaneous breathing activity (ventilator triggering), since 6 hours and no longer than 48 hours * patient for full active management at this point. exclusion criteria: * age \<18 years old * pregnancy * active air leaks * moribund state * high icp * patient has passed a spontaneous breathing trial (if performed for clinical indication) * known copd with history of home oxygen therapy and/or non invasive ventilation and/or gold iii-iv. non invasive ventilation for sleep apnea is not an exclusion criteria.
normative brain volume profiles from multicenter fetal mri

Conditions: Cortical Development Malformation; Multiparametric Magnetic Resonnance Imaging; Brain Cortical Thickness; Prenatal Diagnosis; Fetal Development

Summary: fetal brain mri is an essential diagnostic tool to inform parents about the prognosis of abnormalities detected on routine ultrasound. recent work has shown that brain mri measurements at the antenatal stage are predictive of the child's postnatal development. however, this work remains limited to basic research, in part because of the lack of normative curves of brain tissue volume evolution from fetal mri acquired in clinical routine. this project aims to fill this gap. for this purpose, the project will exploit fetal mri scans acquired in 4 french hospitals (marseille, nice, montpellier and paris): mri scans without abnormalities will be centralized for analysis, and families who have undergone these scans will be contacted to evaluate the development of their children after birth. normative curves will be established by applying a set of treatments developed by the laboratory in marseille collaborating in the project. ultimately, these curves will help to clarify the diagnosis of fetuses by providing a quantitative characterization of the normality of brain measurements.


Eligibility criteria:
inclusion criteria: child who has had, more than 3 years ago, a cerebral mri during the fetal period in one of the 4 partner centers exclusion criteria: * child suffering from a commissural malformation (anomaly of the corpus callosum) * child with a genetic syndrome and/or chromosomal abnormality and/or deleterious mutation * child with syndromic extra-cerebral malformations (including cardiac malformations) * child with intrauterine growth restriction reported in the obstetrical record * child with maternal-fetal infection (torch, parvovirus or other) confirmed by amniotic fluid test or neonatal urine test * multiple pregnancy * mother with diabetes treated during pregnancy (including gestational diabetes, if treated) * mother with antiepileptic medication during pregnancy * alcohol or drug use * presence of a sustentorial arachnoid cyst * presence of an arachnoid cyst with mass effect * objection from parental authority holders to participate in the study
using new ultrasound techniques to assess peritoneal fibrosis in peritoneal dialysis patients

Conditions: Peritoneal Sclerosis

Summary: explore the role of new ultrasound techniques in the assessment of peritoneal fibrosis and encapsulating peritoneal sclerosis in peritoneal dialysis patients


Eligibility criteria:
inclusion criteria: * esrd patients on pd * pd duration ≤12 months or ≥10 years * age between 18-75years exclusion criteria: * refusing to sign up informed consent
king video laryngoscope versus direct laryngoscopy for prehospital intubation: a randomized controlled trial

Conditions: Respiratory Failure

Summary: the goal of this study is to compare the first pass success rate of intubation between video assisted intubation and traditional direct visualization intubation in the field by emergency medical service (ems) professionals

we will equip several local advanced life support ambulances with a low cost video laryngoscope for a total of 12 months. we will outfit ½ of the ambulance crews with the king video laryngoscope (kvl) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (dl). after 6 months, the groups will switch devices. we will randomly assign those ambulances that first use the kvl. after one year (12 months) we will compare the outcomes between the two methods including first pass intubation success, total success rate for intubation, and complications (need for surgical airway, rescue device, need to revert from kvl to dl, etc.). please see the attached protocol page for additional details.

Eligibility criteria:
inclusion criteria: * all patients \>= age 18 year of age undergoing eti in the prehospital setting exclusion criteria: * age \< 18 years of age

Keywords: intubation, laryngoscopy, prehospital, emergency medical services
optical coherence tomography angiography compared to maternal doppler in screening for hypertension in pregnancy

Conditions: Pregnancy Induced Hypertension

Summary: pregnancy related hypertension is one of the most prevalent obstetric complications. the aim of the study is to evaluate the validity and sensitivity of oct angiography in prediction of pregnancy induced hypertensive disorders in comparison to maternal doppler in the first and second trimesters of pregnancy


Eligibility criteria:
inclusion criteria: * pregnant women in the first and second trimesters exclusion criteria: * pregnant females with associated systemic vascular disease as diabetes, sle
combination chemotherapy in treating patients with platinum-resistant recurrent ovarian cancer

Conditions: Ovarian Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.

objectives: * determine the response rate, progression time, and survival of patients with platinum-resistant ovarian cancer treated with weekly paclitaxel and gemcitabine. * determine the toxic effects of this regimen in these patients. * evaluate the toxic effects and safety profile of premedication with steroids with this regimen in these patients. outline: patients are stratified according to prior treatment with paclitaxel (none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel). patients receive dexamethasone iv, then paclitaxel iv followed by gemcitabine iv, for 3 consecutive weeks on days 1, 8, and 15. treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity. all patients are followed until death. projected accrual: approximately 18-35 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed recurrent ovarian epithelial cancer * platinum resistant disease defined as: * progression during the most recent platinum-based chemotherapy or * relapse less than 6 months after platinum-based chemotherapy * measurable or evaluable disease * elevated ca-125 only allowed * positive cytology only not eligible patient characteristics: age: * 18 and over performance status: * swog 0-2 hematopoietic: * granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin less than 2 times upper limit of normal (uln) * ast less than 3 times uln renal: * creatinine no greater than 2 mg/dl neurologic: * no peripheral neuropathy greater than grade 2 other: * no other serious medical illness or psychiatric conditions. prior concurrent therapy: biologic therapy: * no concurrent hematopoietic growth factors chemotherapy: * see disease characteristics * no prior gemcitabine * no prior paclitaxel administered weekly endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * recovered from acute toxic effects secondary to prior therapy

Keywords: recurrent ovarian epithelial cancer
hydroxy chloroquine and covid in ra patients

Conditions: COVID

Summary: evaluation of the clinical course of covid-19 in a cohort of patients with rheumatoid arthritis treated with or without hydroxychloroquine.

study settings \& sample: this is an observational, retrospective -case-control, single-center study. this study will include patients who meet the inclusion criteria followed in the department of rheumatology and rehabilitation, tanta university hospital, tanta, egypt. data will be taken from the medical records of patients with rheumatoid arthritis in the outpatient clinic of the rheumatology and rehabilitation department, tanta university hospital, tanta, egypt. all patients will sign the informed consent form authorizing the collection of these data. group classification a) patients with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen. b) patients with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen. data will be collected and analyzed from patient medical records. it will include the following: 1. epidemiologic, demographic, and clinical data. 2. severity of rheumatoid arthritis. 3. rheumatoid arthritis activity state using the clinical disease activity index 4. dose and duration of hydroxychloroquine 5. need for hospitalization, length of hospital stay, and icu admission including the need for mechanical ventilation. 6. duration from the start of symptoms until clinical cure. 7. severity of covid-19 disease according to the world health organization interim guidance 8. prognosis. laboratory investigations and imaging: 1. complete blood count. 2. renal and liver function tests. 3. random blood sugar. 4. lactate dehydrogenase, d-dimer. 5. serum ferritin, c-reactive protein, 6. chest radiographs or ct scan

Eligibility criteria:
inclusion criteria: * adult patients with rheumatoid arthritis superinfected with covid-19 exclusion criteria: * insufficient data are available in the medical record.

Keywords: covid-19 hydroxy chloroquine rheumatoid
bms-986012 in relapsed/refractory sclc

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of bms-986012 alone and in combination with nivolumab in patients with relapsed/refractory sclc.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histological or cytological confirmed small cell lung cancer (sclc) * performance status 0-1 * adequate organ function * measurable disease exclusion criteria: * known or suspected brain metastasis * small cell cancer not lung in origin * significant or acute medical illness * uncontrolled or significant cardiac disease * infection * ≥ grade 2 peripheral neuropathy * concomitant malignancies * hiv related disease or known or suspected hiv+ * hepatitis b or c infection * ecg abnormalities as defined by the protocol * allergies or hypersensitivities to monoclonal antibodies, bms-986012 or related compounds, including fucosyl-gm1 vaccine and nivolumab other protocol defined inclusion/exclusion criteria could apply
clinical efficacy of postpartum immunization of rh and coombs negative women with sensitization risk.

Conditions: Pregnancy; Fetomaternal Hemorrhage

Summary: this a open, prospective, multicenter, single-arm, phase iii study for clinical assessment of anti-rh immunoglobulin (kamrho-d®) in rh and coombs negative women with risk sensitization. the anti-rh immunoglobulin is an immunobiological containing high concentration of specific antibodies against factor d and "neutralizes" d antigen present in the rh-positive fetal red blood cells (rh +), which passed into the bloodstream of rh-negative pregnant women (rh).

this a phase iii study in which women participants with rh and coombs negative will receive only one dose of 1500 iu anti-rh immunoglobulin intramuscularly up to 72 hours post exposition (child-birth) and will be following until six months to verification of negative coombs maintenance. safety evaluation data will include report of all adverse events (including type, frequency, intensity, seriousness, severity and action taken related to the investigational product).

Eligibility criteria:
inclusion criteria: * agree to participate, sign and date icf; * 18 years old or older; * mothers who are rh-negative, negative indirect coombs analyzed by gel agglutination method, whose just deliveries rh positive baby. exclusion criteria: * be participating simultaneously or have participated in another clinical trial within the last 12 months; * mothers who are allergic to any components of the formula; * mothers who have a history of iga deficiency or iga antibody present; * mothers who have a history of autoimmune hemolytic anemia with hemolysis or with pre-existing risk of hemolysis; * mothers who have indirect coombs test positive at the beginning of the treatment; * rh-negative mothers whose delivered rh-negative babies; * abnormalities of the coagulation system; * patients who made use of vaccines made with live pathogens in the last 03 months or will make during the study; * patients with clinical diagnosis of prenatal liver and / or severe nephropathy; * principal investigator of the study criteria.

Keywords: fmh; anti-rh; efficacy
a study of guselkumab subcutaneous therapy in participants with moderately to severely active crohn's disease

Conditions: Crohn Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with crohn's disease.


Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease (cd) of at least 3 months in duration * have moderate to severe cd as assessed by cdai, stool frequency, and abdominal pain score, and simple endoscopic score for crohn's disease (ses-cd). * demonstrated intolerance or inadequate response to conventional or to biologic therapy for cd exclusion criteria: * current diagnosis of ulcerative colitis or indeterminate colitis * complications of crohn's disease that require surgical intervention or confound efficacy assessments * unstable doses of concomitant crohn's disease therapy
a study to estimate the occurrence of rotavirus gastroenteritis in children < 5 years of age, in bulgaria and latvia

Conditions: Infections, Rotavirus

Summary: this study aims to estimate the real situation of rotavirus gastroenteritis (rv ge) in the primary care settings of both bulgaria and latvia in children less than 5 years of age.

a primary care setting will include independent general practitioners (gp) (specialised in paediatrics) or independent paediatricians. stool samples will be collected from all enrolled subjects at visit 1 (day 0) and tested immediately after collection. the stool sample will be stored for 24 hours only, in case the test cannot be performed immediately after collection.

Eligibility criteria:
inclusion criteria: * infants/children with home visits by the gpgp/paediatrician for the treatment of age or brought to the gp/paediatrician for age treatment during the study period. * a male or female infant/child less than five years of age at the time of the gp/paediatrician visit. a child becomes ineligible on the day of her/his fifth birthday. * written informed consent obtained from the parents/legally acceptable representative (lars) of the subject. * subjects who the investigator believes that his/her, parents/lars can and will comply with the requirements of the protocol. exclusion criteria: • child in care.

Keywords: bulgaria primary care settings children latvia acute gastroenteritis
drug use investigation for adoair (fluticasone/salmeterol)

Conditions: Respiratory Disorders

Summary: the purpose of this post-marketing surveillance is to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy in the japanese asthma patients treated with fluticasone propionate and salmeterol xinafoate.


Eligibility criteria:
inclusion criteria: * must use fluticasone and salmeterol for the first time exclusion criteria: * patients with hypersensitivity to salmeterol and fluticasone * patients with infection which salmeterol and fluticasone is not effective * patients with deep mycosis